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Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns (NIV)

Primary Purpose

Bronchopulmonary Dysplasia

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

binasal prongs

nasal mask

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring cpap failure, bronchopulmonary dysplasia, nasal trauma, ventilation duration, non-invasive ventilation

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit

Exclusion Criteria:

who are intubated in delivery room or neonatal intensive care unit before randomization
with congenital anomaly
patients who require NIV more than 3 days

Sites / Locations

Ankara UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nasal Mask

nasal prong

Arm Description

patients who receive NIV by nasal mask interface after randomization

patients who receive NIV by nasal prongs as interface after randomization

Outcomes

Primary Outcome Measures

failure of NIV

patients who require endotracheal intubation after NIV treatment

Secondary Outcome Measures

ventilation duration

both NIV and mechanical ventilation durations will be evaluated

Full Information

NCT ID

NCT01989442

First Posted

November 15, 2013

Last Updated

January 14, 2015

Sponsor

Ankara University

1. Study Identification

Unique Protocol Identification Number

NCT01989442

Brief Title

Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns

Acronym

NIV

Official Title

Efficacy and Safety of Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ankara University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study aims to investigate efficacy and safety of nasal mask and prongs used in non-invasive ventilation in newborns by using esophageal pressure transducer. The parameters including ventilation duration, hospitalization duration, pulmonary outcomes and side effects will be evaluated.

Detailed Description

Although it seems as more non-invasive there is still lack of data especially on efficacy of nasal mask use in NIV for newborns. By using esophageal pressure transducers we will evaluate the pressure supplied by the ventilation mode and compare it with more commonly used nasal prongs. The investigators will test the hypothesis of equivalence of nasal mask in comparison to prongs with better safety parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia

Keywords

cpap failure, bronchopulmonary dysplasia, nasal trauma, ventilation duration, non-invasive ventilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nasal Mask

Arm Type

Experimental

Arm Description

patients who receive NIV by nasal mask interface after randomization

Arm Title

nasal prong

Arm Type

Active Comparator

Arm Description

patients who receive NIV by nasal prongs as interface after randomization

Intervention Type

Device

Intervention Name(s)

binasal prongs

Other Intervention Name(s)

viasys healthcare infant flow system- binasal prongs

Intervention Description

patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support

Intervention Type

Device

Intervention Name(s)

nasal mask

Other Intervention Name(s)

viasys healthcare infant flow system-nasal mask

Intervention Description

patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support

Primary Outcome Measure Information:

Title

failure of NIV

Description

patients who require endotracheal intubation after NIV treatment

Time Frame

1 year

Secondary Outcome Measure Information:

Title

ventilation duration

Description

both NIV and mechanical ventilation durations will be evaluated

Time Frame

3 days

Other Pre-specified Outcome Measures:

Title

bronchopulmonary dysplasia

Description

oxygen or pressure requirement on postmenstrual 36 weeks of gestational age

Time Frame

1 year

Title

septal trauma rate

Description

any destruction on nose that require treatment after use of NIV

Time Frame

1 year

10. Eligibility

Sex

All

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit Exclusion Criteria: who are intubated in delivery room or neonatal intensive care unit before randomization with congenital anomaly patients who require NIV more than 3 days

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ankara University

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saadet ARSAN, Professor

Organizational Affiliation

Ankara University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ankara University

City

Ankara

ZIP/Postal Code

06300

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ufuk Cakir

Phone

905058581781

drufukcakir@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

23897911

Citation

McCarthy LK, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. A randomized trial of nasal prong or face mask for respiratory support for preterm newborns. Pediatrics. 2013 Aug;132(2):e389-95. doi: 10.1542/peds.2013-0446. Epub 2013 Jul 29.

Results Reference

background

PubMed Identifier

23090339

Citation

Kieran EA, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants. Pediatrics. 2012 Nov;130(5):e1170-6. doi: 10.1542/peds.2011-3548. Epub 2012 Oct 22.

Results Reference

background

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Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns

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